81 FR 20417 - Importer of Controlled Substances Application: Stepan Company
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 67 (April 7, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 67 (April 7, 2016)
| Page Range | 20417-20418 | |
| FR Document | 2016-07944 |
[Federal Register Volume 81, Number 67 (Thursday, April 7, 2016)] [Notices] [Pages 20417-20418] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07944] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Stepan Company ACTION: Notice of application. ----------------------------------------------------------------------- DATES: Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before May 9, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 9, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Registe Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearing on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007). [[Page 20418]] SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (``Deputy Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on February 12, 2016, Stepan Company, Natural Products Dept., 100 W. Hunter Avenue, Maywood, New Jersey 07607 applied to be registered as an importer of coca leaves (9040), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance in bulk for the manufacture of controlled substance for distribution to its customers. Dated: March 28, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-07944 Filed 4-6-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 67 / Thursday, April 7, 2016 / Notices 20417
diphosphonic acid (‘‘HEDP’’) from Commission antidumping duty and elaborates upon the Commission’s rules
China, provided for in subheading countervailing duty investigations. The with respect to electronic filing.
2931.90.90 of the Harmonized Tariff Secretary will prepare a public service In accordance with sections 201.16(c)
Schedule of the United States, that are list containing the names and addresses and 207.3 of the rules, each document
alleged to be sold in the United States of all persons, or their representatives, filed by a party to the investigations
at less than fair value and alleged to be who are parties to these investigations must be served on all other parties to
subsidized by the Government of China. upon the expiration of the period for the investigations (as identified by
Unless the Department of Commerce filing entries of appearance. either the public or BPI service list), and
extends the time for initiation, the Limited disclosure of business a certificate of service must be timely
Commission must reach preliminary proprietary information (BPI) under an filed. The Secretary will not accept a
determinations in antidumping and administrative protective order (APO) document for filing without a certificate
countervailing duty investigations in 45 and BPI service list.—Pursuant to of service.
days, or in this case by May 16, 2016. section 207.7(a) of the Commission’s
Authority: These investigations are being
The Commission’s views must be rules, the Secretary will make BPI conducted under authority of title VII of the
transmitted to Commerce within five gathered in these investigations Tariff Act of 1930; this notice is published
business days thereafter, or by May 23, available to authorized applicants pursuant to section 207.12 of the
2016. representing interested parties (as Commission’s rules.
DATES: Effective Date: March 31, 2016.
defined in 19 U.S.C. 1677(9)) who are By order of the Commission.
parties to the investigations under the
FOR FURTHER INFORMATION CONTACT: Dated: April 4, 2016.
APO issued in the investigations,
Edward Petronzio (202–205–3176), Lisa R. Barton,
provided that the application is made
Office of Investigations, U.S. Secretary to the Commission.
not later than seven days after the
International Trade Commission, 500 E publication of this notice in the Federal [FR Doc. 2016–07987 Filed 4–6–16; 8:45 am]
Street SW., Washington, DC 20436. Register. A separate service list will be BILLING CODE 7020–02–P
Hearing-impaired persons can obtain maintained by the Secretary for those
information on this matter by contacting parties authorized to receive BPI under
the Commission’s TDD terminal on 202– the APO.
205–1810. Persons with mobility DEPARTMENT OF JUSTICE
Conference.—The Commission’s
impairments who will need special Director of Investigations has scheduled
assistance in gaining access to the Drug Enforcement Administration
a conference in connection with these
Commission should contact the Office investigations for 9:30 a.m. on April 21, [Docket No. DEA–392]
of the Secretary at 202–205–2000. 2016, at the U.S. International Trade
General information concerning the Commission Building, 500 E Street SW., Importer of Controlled Substances
Commission may also be obtained by Washington, DC. Requests to appear at Application: Stepan Company
accessing its Internet server (http:// the conference should be emailed to
www.usitc.gov). The public record for William.bishop@usitc.gov and ACTION: Notice of application.
this investigation may be viewed on the Sharon.bellamy@usitc.gov (DO NOT
Commission’s electronic docket (EDIS) DATES: Registered bulk manufacturers of
FILE ON EDIS) on or before April 19,
at http://edis.usitc.gov. the affected basic class, and applicants
2016. Parties in support of the
SUPPLEMENTARY INFORMATION:
therefore, may file written comments on
imposition of countervailing and
Background.—These investigations or objections to the issuance of the
antidumping duties in these
are being instituted, pursuant to investigations and parties in opposition proposed registration in accordance
sections 703(a) and 733(a) of the Tariff to the imposition of such duties will with 21 CFR 1301.34(a) on or before
Act of 1930 (19 U.S.C. 1671b(a) and each be collectively allocated one hour May 9, 2016. Such persons may also file
1673b(a)), in response to a petition filed within which to make an oral a written request for a hearing on the
on March 31, 2016, by Compass presentation at the conference. A application pursuant to 21 CFR 1301.43
Chemical International LLC, Smyrna, nonparty who has testimony that may on or before May 9, 2016.
Georgia. aid the Commission’s deliberations may ADDRESSES: Written comments should
For further information concerning request permission to present a short be sent to: Drug Enforcement
the conduct of these investigations and statement at the conference. Administration, Attention: DEA Federal
rules of general application, consult the Written submissions.—As provided in Registe Representative/ODW, 8701
Commission’s Rules of Practice and sections 201.8 and 207.15 of the Morrissette Drive, Springfield, Virginia
Procedure, part 201, subparts A and B Commission’s rules, any person may 22152. All request for hearing must be
(19 CFR part 201), and part 207, submit to the Commission on or before sent to: Drug Enforcement
subparts A and B (19 CFR part 207). April 26, 2016, a written brief Administration, Attn: Administrator,
Participation in the investigations and containing information and arguments 8701 Morrissette Drive, Springfield,
public service list.—Persons (other than pertinent to the subject matter of the Virginia 22152. All request for hearing
petitioners) wishing to participate in the investigations. Parties may file written should also be sent to: (1) Drug
investigations as parties must file an testimony in connection with their Enforcement Administration, Attn:
entry of appearance with the Secretary presentation at the conference. All Hearing Clerk/LJ, 8701 Morrissette
to the Commission, as provided in written submissions must conform with Drive, Springfield, Virginia 22152; and
mstockstill on DSK4VPTVN1PROD with NOTICES
sections 201.11 and 207.10 of the the provisions of section 201.8 of the (2) Drug Enforcement Administration,
Commission’s rules, not later than seven Commission’s rules; any submissions Attn: DEA Federal Register
days after publication of this notice in that contain BPI must also conform with Representative/ODW, 8701 Morrissette
the Federal Register. Industrial users the requirements of sections 201.6, Drive, Springfield, Virginia 22152.
and (if the merchandise under 207.3, and 207.7 of the Commission’s Comments and requests for hearing on
investigation is sold at the retail level) rules. The Commission’s Handbook on applications to import narcotic raw
representative consumer organizations E-Filing, available on the Commission’s material are not appropriate. 72 FR
have the right to appear as parties in Web site at http://edis.usitc.gov, 3417, (January 25, 2007).
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![20418 Federal Register / Vol. 81, No. 67 / Thursday, April 7, 2016 / Notices
SUPPLEMENTARY INFORMATION: The The DEA has considered the factors in DEPARTMENT OF JUSTICE
Attorney General has delegated her 21 U.S.C. 823, 952(a) and 958(a) and
authority under the Controlled determined that the registration of Drug Enforcement Administration
Substances Act to the Administrator of Fisher Clinical Services, Inc. to import
the Drug Enforcement Administration the basic classes of controlled [Docket No. DEA–392]
(DEA), 28 CFR 0.100(b). Authority to substances is consistent with the public
exercise all necessary functions with interest and with United States Bulk Manufacturer of Controlled
respect to the promulgation and obligations under international treaties, Substances Application: Navinta, LLC
implementation of 21 CFR part 1301, conventions, or protocols in effect on
incident to the registration of ACTION: Notice of application.
May 1, 1971. The DEA investigated the
manufacturers, distributors, dispensers, company’s maintenance of effective
importers, and exporters of controlled DATES: Registered bulk manufacturers of
controls against diversion by inspecting
substances (other than final orders in the affected basic classes, and
and testing the company’s physical applicants therefore, may file written
connection with suspension, denial, or
security systems, verifying the comments on or objections to the
revocation of registration) has been
redelegated to the Deputy Assistant company’s compliance with state and issuance of the proposed registration in
Administrator of the DEA Office of local laws, and reviewing the company’s accordance with 21 CFR 1301.33(a) on
Diversion Control (‘‘Deputy Assistant background and history. or before June 6, 2016.
Administrator’’) pursuant to section 7 of Therefore, pursuant to 21 U.S.C. ADDRESSES: Written comments should
28 CFR part 0, appendix to subpart R. 952(a) and 958(a), and in accordance be sent to: Drug Enforcement
In accordance with 21 CFR with 21 CFR 1301.34, the above-named Administration, Attention: DEA Federal
1301.34(a), this is notice that on company is granted registration as an Register Representative/ODW, 8701
February 12, 2016, Stepan Company, importer of the following basic classes Morrissette Drive, Springfield, Virginia
Natural Products Dept., 100 W. Hunter of controlled substances: 22152.
Avenue, Maywood, New Jersey 07607
applied to be registered as an importer Controlled substance Schedule SUPPLEMENTARY INFORMATION: The
of coca leaves (9040), a basic class of Attorney General has delegated her
controlled substance listed in schedule Methylphenidate (1724) ............. II authority under the Controlled
II. Levorphanol (9220) ................... II Substances Act to the Administrator of
The company plans to import the Noroxymorphone (9668) ............ II the Drug Enforcement Administration
listed controlled substance in bulk for Tapentadol (9780) ..................... II (DEA), 28 CFR 0.100(b). Authority to
the manufacture of controlled substance exercise all necessary functions with
for distribution to its customers. The company plans to import the respect to the promulgation and
implementation of 21 CFR part 1301,
Dated: March 28, 2016. listed substances for analytical research,
incident to the registration of
Louis J. Milione, testing, and clinical trials. This
manufacturers, distributors, dispensers,
Deputy Assistant Administrator. authorization does not extend to the
importers, and exporters of controlled
[FR Doc. 2016–07944 Filed 4–6–16; 8:45 am] import of a finished FDA approved or substances (other than final orders in
BILLING CODE 4410–09–P non-approved dosage form for connection with suspension, denial, or
commercial distribution in the United revocation of registration) has been
States. redelegated to the Deputy Assistant
DEPARTMENT OF JUSTICE The company plans to import an Administrator of the DEA Office of
intermediate form of tapentadol (9780) Diversion Control (‘‘Deputy Assistant
Drug Enforcement Administration
to bulk manufacture tapentadol for Administrator’’) pursuant to section 7 of
[Docket No. DEA–392] distribution to its customers. Placement 28 CFR part 0, appendix to subpart R.
of these (this) drug code (s) onto the In accordance with 21 CFR
Importer of Controlled Substances company’s registration does not 1301.33(a), this is notice that on
Registration: Fisher Clinical Services, September 10, 2015, Navinta, LLC, 1499
translate into automatic approval of
Inc. Lower Ferry Road, Ewing, New Jersey
subsequent permit applications to
ACTION: Notice of registration. import controlled substances. Approval 08618–1414 applied to be registered as
of permit applications will occur only a bulk manufacturer of the following
SUMMARY: Fisher Clinical Services, Inc. when the registrant’s business activity is basic classes of controlled substances:
applied to be registered as an importer consistent with what is authorized
of certain basic classes of controlled Controlled substance Schedule
under to 21 U.S.C. 952(a)(2).
substances. The Drug Enforcement Authorization will not extend to the Pentobarbital (2270) ............... II
Administration (DEA) grants Fisher import of FDA approved or non- 4-Anilino-N-phenethyl-4-piper- II
Clinical Services, Inc. registration as an approved finished dosage forms for idine (ANPP) (8333).
importer of those controlled substances. commercial sale. Remifentanil (9739) ................. II
SUPPLEMENTARY INFORMATION: By notice Fentanyl (9801) ....................... II
Dated: March 28, 2016.
dated December 9, 2015, and published
Louis J. Milione,
mstockstill on DSK4VPTVN1PROD with NOTICES
in the Federal Register on December 17, The company plans initially to
2015, 80 FR 78766, Fisher Clinical Deputy Assistant Administrator. manufacture API quantities of the listed
Services, Inc., 7554 Schantz Road, [FR Doc. 2016–07945 Filed 4–6–16; 8:45 am] controlled substances for validation
Allentown, Pennsylvania 18106 applied BILLING CODE 4410–09–P purposes and FDA approval, then
to be registered as an importer of certain eventually upon FDA approval to
basic classes of controlled substances. produce commercial size batches for
No comments or objections were distribution to dosage form
submitted for this notice. manufacturers.
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Document Created: 2016-04-06 23:44:25
Document Modified: 2016-04-06 23:44:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of application. | |
| Dates | Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before May 9, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 9, 2016. | |
| FR Citation | 81 FR 20417 |
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